Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07553689

Plasma Therapy for Diverse Wounds

This study is a prospective, multicenter, real-world observational study. It aims to evaluate whether adding plasma device therapy to standard wound care is effective and safe for treating different types of wounds, including acute wounds (such as burns and surgical incisions), chronic wounds (such as diabetic foot ulcers and pressure injuries), post-grafting wounds, and sutured wounds.

A total of 500 patients receiving standard wound care plus plasma therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients who received standard wound care alone. The main outcomes include wound healing rate at 4 weeks, time to complete wound closure, pain relief, scar formation, and any side effects. Patients will be followed for up to 6 months.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Wound Care

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of any of the following wound types: acute wounds (burns, trauma, surgical incisions, skin avulsions), chronic wounds (diabetic foot ulcers, pressure injuries, venous ulcers, radiation ulcers, burn residual wounds), post-grafting wounds (autograft or allograft, including donor and recipient sites), or sutured wounds (postoperative incisions, flap surgery, tension-reducing sutures).
  • Age ≥ 12 years (for minors under 18 years, informed consent must be provided by a parent or legal guardian).
  • Stable vital signs and able to tolerate wound treatment.
  • Willing to participate and able to provide signed informed consent.

Exclusion criteria

  • Active malignant tumor involving the wound area.
  • Severe systemic infection or sepsis.
  • Severe immunodeficiency or long-term use of high-dose corticosteroids.
  • Intolerance to plasma therapy or refusal to participate.
  • Pregnancy or breastfeeding.

Treatment and study plan

Plasma Device

Device

Cold atmospheric plasma device used for non-contact wound treatment. The device generates low-temperature plasma with broad-spectrum antibacterial properties, promoting cell proliferation, modulating inflammation, and improving local microcirculation.

Primary outcomes

  1. Complete Wound Healing Rate at 4 Weeks

    Time frame: 4 weeks after enrollment

    Proportion of wounds (acute wounds, post-grafting wounds, and sutured wounds) achieving complete epithelialization without drainage at 4 weeks post-treatment.

  2. Proportion of Wounds Achieving ≥50% Area Reduction at 4 Weeks

    Time frame: 4 weeks after enrollment

    For chronic wounds (diabetic foot ulcers, pressure injuries, venous ulcers, radiation ulcers, etc.), the proportion of wounds showing a reduction in wound area of 50% or more compared to baseline at 4 weeks.

Secondary outcomes

  1. Time to Complete Wound Healing

    Time frame: From enrollment to complete epithelialization, assessed up to 6 months

    Number of days from initial treatment to complete wound closure (100% re-epithelialization).

  2. Change in Pain Score (VAS)

    Time frame: Baseline, day 3, day 7, day 14, day 21, day 28

    Pain intensity is measured using the Visual Analog Scale (VAS). Scores range from 0 to 10, where higher scores indicate worse pain (0 = no pain, 10 = worst possible pain).

  3. Change in Pain Relief/Satisfaction (ASA)

    Time frame: Baseline, day 3, day 7, day 14, day 21, day 28

    Pain relief and satisfaction are measured using the Analog Scale of Appreciation (ASA). Scores range from 0 to 10, where higher scores indicate better pain relief or greater satisfaction (0 = no appreciation/relief, 10 = complete appreciation/relief).

  4. Wound Area Reduction Rate

    Time frame: Day 7, day 14, day 28

    Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%.

  5. Scar Assessment

    Time frame: Month 1, month 3, month 6

    Scar quality is evaluated using the Vancouver Scar Scale (VSS) , which assesses vascularity, pigmentation, pliability, and height. The total score ranges from 0 to 13, with higher scores indicating worse scar quality (e.g., greater vascularity, pigmentation, thickness, and reduced pliability).

  6. Wound Recurrence Rate

    Time frame: Proportion of participants experiencing recurrence of a wound at the same anatomical site within 6 months after complete healing.

    6 months after enrollment

  7. Functional Recovery - Local Sensory Function

    Time frame: 6 months after enrollment

    Local sensory function of the healed wound area is assessed by sensory testing. Unit of Measure: Present vs. absent (or reduced) sensation; or specific monofilament rating (e.g., 2.0-6.0). Higher scores or "present" indicate better sensory function.

  8. Functional Recovery - Sweating Function

    Time frame: 6 months after enrollment

    Sweating function of the healed wound area is assessed by sweat test (e.g., starch-iodine test).

    Unit of Measure: Present vs. absent (or reduced) sweating; or area of sweating (cm²). Higher scores or "present" indicate better sweating function.

Other outcomes

  1. Incidence of Adverse Events

    Time frame: From enrollment to 6 months follow-up

    Proportion of participants experiencing local adverse reactions (burns, erythema, blisters, increased exudate, allergy) or systemic adverse reactions (fever, infection spread). Rate of treatment discontinuation due to adverse events will also be recorded.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

A Prospective, Multicenter, Real-World Observational Study of a Plasma Device for Adjunctive Therapy in Acute Wounds, Chronic Wounds, Post-Grafting Wounds, and Sutured Wounds

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.